Disease-specific Quality Of Life Research Articles

Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.

Atopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream. The aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2. In the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]). A total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p<0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p<0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p<0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52). Consistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available). ClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).

German language adaptation of the Cluster Headache Quality of Life Scale (CH-QoL)

BackgroundCluster headache (CH) can lead to high disability and reduced quality of life (QoL). QoL should be assessed as an important outcome both in research and in clinical care. The 28-item Cluster Headache Quality of Life Scale (CH-QoL) is a valid self-report questionnaire to assess disease-specific QoL. A German version is lacking. This study aims to develop a German-language version and to determine its psychometric properties.MethodsThe CH-QoL was translated into German by two headache experts and blindly back-translated by two professional translators. Additionally, the CH-QoL was tested for comprehensibility by nine persons with CH. In this multi-stage process, linguistic discrepancies were repeatedly discussed in an expert panel and appropriate modifications were conducted to optimize the translation. A cross-sectional online survey, comprising the CH-QoL and further self-report questionnaires such as the Cluster Headache Scales (CHS), yielded a sample of N = 106 persons with CH (53.8% female, M = 45.5 [SD = 11.8] years, 48.1% episodic CH, 51.9% chronic CH, 79.2% currently having recurring CH attacks).ResultsExploratory factor analysis revealed two clearly interpretable factors (“restriction of activities of daily living”, and “impact on mood and interpersonal relationships”), which is in discrepancy to the four factors of the original English version. The model fit was good, with χ2(323) = 590.74, p < .001, RMSEA = 0.088, SRMR = 0.053, TLI = 0.857. Reliability was very good (McDonald’s omega ω = 0.97, Subscale/Factor 1: ω = 0.96, Subscale/Factor 2: ω = 0.92). Correlational analyses (correlations with related questionnaires as well as with clinical parameters) confirmed convergent validity.ConclusionsSince the German version of the CH-QoL has very good psychometric properties, it is suitable for the assessment of disease-specific QoL in people with CH in German-speaking countries.Trial registrationThis study is registered with the German Clinical Trials Register (DRKS-ID: DRKS00028475, registration date 03 March 2022).

Maximal exercise capacity, peripheral muscle strength, sleep quality, and quality of life in adult patients with stable asthma

ABSTRACT Objective The prevalence of asthma is increasing gradually worldwide. The pathophysiological process of asthma causes some alterations in the respiratory system and decreases oxygen-carbon dioxide exchange and respiration volume. These alterations may affect maximal exercise capacity, peripheral muscle strength, sleep quality, and disease-specific quality of life but have yet to be comprehensively investigated. To compare maximal exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, sleep quality, and quality of life in adult patients with asthma, healthy controls were aimed. Methods Forty-one adult stable asthmatic patients (GINA I-III) and 41 healthy subjects were compared. Exercise capacity (cardiopulmonary exercise test [CPET]), pulmonary function (spirometry), peripheral muscle strength (dynamometer), dyspnea (modified Medical Research Council [mMRC] dyspnea scale), quality of life (Asthma Quality of Life Questionnaire [AQLQ]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) were evaluated. Results Peak VO2, VO2kg, MET, VE, HR, %VE, %HR, VCO2 parameters of CPET, FVC, FEV1, FEF25-75%, and FEV1/FVC and quadriceps femoris, shoulder abductors, and hand grip muscles strength were significantly decreased in patients with asthma (p < 0.05). MMRC dyspnea scale score was increased, and AQLQ and PSQI scores decreased in asthma patients (p < 0.05). Conclusions Cardiac and pulmonary system responses to peak exercise worsened, and maximal exercise capacity and peripheral muscle strength decreased in adult patients with stable asthma. In addition, dyspnea during daily activities increases, and quality of life and sleep quality are impaired. A variety of exercise training that would benefit asthmatic patients' outcomes should be investigated.

Long-Term Quality of Life Among Patients Undergoing Endoscopic Pituitary Gland Surgery.

Introduction/Objectives: The endoscopic approach to skull base lesions is widely regarded as less invasive and associated with reduced morbidity, offering favorable outcomes, particularly in terms of short-term quality of life (QOL). However, to date, long-term assessments of both nasal function and tumor-related QOL remain limited. To evaluate patients' long-term nasal- and tumor-related QOL after endoscopic endonasal resection of pituitary tumors and to detect predictors for poor postoperative QOL. Study Design: This study was a prospective cohort study. Methods: All patients with pituitary adenomas who underwent trans-sphenoidal surgery at Tel Aviv Sourasky Medical Center between 2014 and 2021 were recruited. Recruited patients completed the Anterior Skull Base Disease-Specific QOL (ASBS-Q) questionnaire and the Sinonasal Outcome Test 22 (SNOT-22) questionnaire before surgery and 1, 2, and 3-5 years after surgery. Clinical data were collected and analyzed. Results: The study included 43 patients (18 women). No significant decrease was observed in tumor-related quality of life (QOL) scores, measured by ASBS-Q and SNOT-22, throughout the 5-year follow-up period. SNOT-22 score differences from the preoperative baseline at years 1, 3, and 5 were 0.81 [-4.84-6.58], 3.35 [-4.32-11.02], and 3.73 [-2.22-9.68], respectively, with no statistically significant changes. ASBS-Q scores similarly showed no significant changes over time. Subgroup analyses revealed that tumor characteristics (secreting vs. non-secreting, size), surgical factors (intraoperative cerebrospinal fluid leak, gross tumor resection, use of nasoseptal flap), and endocrine remission did not significantly impact QOL (p > 0.05 for all variables). Conclusions: Our study demonstrated that patients who underwent endoscopic pituitary lesion resection maintained high nasal- and tumor-related quality of life over a 5-year follow-up period. However, given the limitations of our study, further multi-center studies with larger patient populations are warranted to validate these results.

External Factors Modulating Pain and Pain-Related Functional Impairment in Cervical Dystonia.

Little is known about factors modulating pain and pain-related functional impairment in isolated cervical dystonia (CD). The aim was to assess the prevalence and interrelationship between pain-modulating factors and pain-related determinants of functional impairment and quality of life in CD. We analyzed pain-aggravating and pain-relieving external factors, the degree of pain-related functional impact on routine activities, and the relationship between these and pain severity, using cross-sectional data collected using the Pain in Dystonia Scale (PIDS) from 85 participants with CD. Pairwise correlation analyses and age- and sex-adjusted linear regression models estimated the relationship between pain-modulating factors and pain severity, and the impact of pain severity, dystonia severity, and psychiatric symptoms on pain-related functional impairment and disease-specific quality of life (measured using the Craniocervical Dystonia Questionnaire-24). Stress and prolonged fixed position were the most frequent and impacting pain triggers, with women reporting larger impact. The average impact of pain-relieving factors was lower than that of pain triggers. Physical exercise and social gatherings were the most impacted activities by pain in CD. The intensity of external modulating factors was a predictor of pain severity. Severity of pain, CD, and psychiatric symptoms independently predicted pain-related functional impairment, whereas quality of life was predicted by pain severity, pain-related functional impairment, and psychiatric symptom severity, but not dystonia severity. The PIDS provides insight into external modulation and functional impact of pain in CD. The pattern of external modulation of pain in CD is in line with a multifactorial modulation and complex physiology.

Effectiveness of the active communication education program in improving the general quality of life of older adults who use hearing aids: a randomized clinical trial

BackgroundHearing loss in older adults affects general, generic health-related and disease-specific quality of life (QoL). The conventional strategy to address it is through hearing aids, which have been shown to improve disease-specific QoL. However, the long-term results regarding general quality of life are unknown, and communication problems and stigma associated with hearing loss may persist. An effective intervention strategy to address these problems is group communication programs, most notably Active Communication Education (ACE). This program has been shown to increase communication strategies and reduce communication activity limitations and participation restrictions. These precedents allow us to hypothesize that this program could improve general QoL.MethodsA randomized clinical trial was conducted on 114 older adult hearing aid users. Fifty-four subjects composed the intervention group that received the ACE program, while 60 subjects composed the control group that received an informational-lectures type intervention. The WHOQOL-BREF questionnaire was used to measure general QoL. Measurements were taken before and right after the intervention, with follow-ups at 6 and 12 months. Multilevel linear mixed models were estimated, considering the WHOQOL-BREF dimension scores and total score as the outcomes, and an interaction term between time since intervention and group as the predictor. Within- and between-group comparisons were made.ResultsCompared to the baseline time-point, the ACE group showed significant improvements right after the intervention, and at the 6-month and 12-month follow-ups for the dimensions of psychological health, social relationships, environment, and total score. Compared to the control group, the ACE group exhibited significantly greater improvements in the social dimension at all postintervention assessments, as well as in the environment dimension and total score at the 12-month follow-up.ConclusionsThe ACE program improved general QoL in terms of social relationships and environment dimensions, which lasted up to 12 months after the intervention. Therefore, ACE is positioned as an effective complement for HA users, enhancing and delivering new benefits related to broader aspects of QoL not necessarily tied to health.Trial registrationISRCTN54021189 (retrospectively registered on 18/07/2023).

The Influence of Kinesiophobia and Pain Catastrophizing on Disease-Specific Quality of Life in Patients With Recurrent Patellofemoral Instability

Background: The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) is a disease-specific, quality of life patient-reported outcome measure (PROM) that is valid and reliable in patients with recurrent lateral patellofemoral instability (LPI). Quality of life encompasses the physical, emotional, and psychological aspects of patient functioning and recovery. Purposes: To concurrently validate the BPII 2.0 to the Tampa Scale for Kinesiophobia (TSK-11), the Pain Catastrophizing Scale (PCS), and the Anterior Cruciate Ligament–Return to Sport after Injury Scale (ACL-RSI) in patients presenting with recurrent LPI and to assess baseline values for the PROMs in patients with LPI. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: A total of 107 consecutive patients with recurrent LPI were assessed between January and October 2021. Patients completed the BPII 2.0, TSK-11, PCS, and ACL-RSI. A Pearson r correlation coefficient was employed to examine relationships between the PROMs. Baseline values, as well as floor and ceiling effects and Cronbach alpha, were assessed for all PROMs. Results: All 107 patients completed the 4 PROMs. Patients included 28 men (26.2%) and 79 women (73.8%), with a mean (SD) age of 25.7 (9.8) years. The mean (SD) age at first dislocation was 14.8 (6.3) years. The TSK-11, PCS, and ACL-RSI were all statistically significantly correlated with the BPII 2.0 (P < .01; 2-tailed), with moderate correlations (r = -0.361-0.628) The R2 values indicated an overlap of the constructs measured by the PROMs. Conclusion: A statistically significant correlation was evident between the BPII 2.0 and the other PROMs. The BPII 2.0 does not explicitly measure kinesiophobia or pain catastrophizing; however, the significant statistical relationship of the TSK-11 and PCS to the BPII 2.0 suggests that this information is being captured and reflected.

Long-term effectiveness of tonsillotomy versus tonsillectomy: A 12-year follow-up study.

To evaluate the long-term effectiveness of tonsillotomy (TT) compared to tonsillectomy (TE) with respect to disease-specific quality of life (QOL), sleep-disordered breathing symptoms, throat infections, and rate of reoperations over a median follow-up period of 12years. All patients < 16years of age who underwent tonsil surgery between 2010 and 2011 at Helsinki University Hospital, Finland, were included in the study. In 2023, the patients answered a questionnaire concerning tonsil-related issues and a modified Tonsil and Adenoid Health Status Instrument (disease-specific QOL). Information about possible revisits and reoperations was gathered. The study population consisted of 189 respondents, of which 87 had undergone TT and 102 TE. The median follow-up was 11.8years in the TT group and 12.4years in the TE group. The disease-specific QOL was equally good in both groups. Throat infections had not been an issue for the vast majority of patients and occurred to the same extent after TT and TE. The majority of participants (79.0% TT, 86.9% TE) were satisfied with the surgery, with no significant differences between the groups. After TT and TE, there were only a few revisits due to tonsil-related problems, and the reoperation rate was 6.9% and 1.0%, respectively. Long-term clinical effectiveness of TT seems excellent. Compared to TE, with TT, equal disease-specific QOL can be achieved with a less invasive surgical method. Over a median follow-up period of 12-years, TT was not shown to be associated with an increased risk of tonsil infection problems.

Rib-sparing subclavian vein decompression in venous thoracic outlet syndrome

ObjectiveVenous thoracic outlet syndrome (VTOS), a compression syndrome of the subclavian vein at the costoclavicular junction, is commonly treated with first rib resection. This invasive procedure carries a risk of serious complications. The purpose of this single-center cross-sectional study was to evaluate the long-term outcome of non-bony decompression by resection of the subclavius muscle and tendon and to provide a detailed description of the procedure. MethodsPatients who underwent rib-sparing decompression for VTOS between July 2014 and September 2023 were analyzed using clinical and radiological examinations. Patient-reported measures were used to assess functional disability and residual symptoms (DASH) and disease-specific quality of life and symptoms (VEINES-QOL/SYM). ResultsTen patients were included in the study. Seven were treated for Paget-Schroetter syndrome and 3 for McCleery syndrome. At mean follow up of 45.4 (SD 31.0) months, all patients reported significant resolution of initial symptoms with patent vasculature on Doppler ultrasonography. All patients had a Villalta PTS score <4, indicating the absence of post-thrombotic syndrome. A mean DASH score of 3.8 (SD 5.3) indicated minimal functional disability. Patients reported minimal overall impact on their quality of life as reflected by the mean VEINES-QOL score of 92.6 (SD 8.9) and low severity of venous symptoms as indicated by the mean VEINES-SYM score of 92.7 (SD 9.8). ConclusionOur analysis suggests that non-bony decompression with resection of the subclavius muscle and tendon is a safe and effective intervention for definitive treatment of VTOS that is less invasive than first rib resection.

Repurposing chemotherapy-induced peripheral neuropathy grading.

Chemotherapy-induced peripheral neuropathy (CIPN) is perceived differently by patients and physicians, complicating its assessment. Current recommendations advocate combining clinical and patient-reported outcomes measures, but this approach can be challenging in patient care. This multicenter European study aims to bridge the gap between patients' perceptions and neurological impairments by aligning both perspectives to improve treatment decision-making. Data were pooled from two prospective studies of subjects (n = 372) with established CIPN. Patient and physician views regarding CIPN were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Total Neuropathy Scale-clinical version (TNSc) items, and the disease-specific quality of life - Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20) from the European Organization for Research and Treatment of Cancer (EORTC). To identify inherent neurotoxic severity patterns, we employed hierarchical cluster analysis optimized with k-means clustering and internally validated by discriminant functional analysis. Both NCI-CTCAE and TNSc demonstrated a significant difference in the distribution of severity grades in relation to QLQ-CIPN20 scores. However, a proportion of subjects with different neurotoxic severity grades exhibited overlapping QLQ-CIPN20 scores. We identified three distinct clusters classifying subjects as having severely impaired, intermediately impaired, and mildly impaired CIPN based on TNSc and QLQ-CIPN20 scores. No differences in demographics, cancer type distribution, or class of drug received were observed. Our results confirm the heterogeneity in CIPN perception between patients and physicians and identify three well-differentiated subgroups of patients delineated by degree of CIPN impairment based on scores derived from TNSc and QLQ-CIPN20. A more refined assessment of CIPN could potentially be achieved using the calculator tool derived from the cluster equations in this study. This tool, which facilitates individual patient classification, requires prospective validation.

Disease-specific patient-reported quality of life after fenestrated/branched endovascular aortic aneurysm repair

ObjectivesFenestrated-branched endovascular technology (F/B-EVAR) is increasingly used to repair complex aortic aneurysms. While reintervention, morbidity and mortality after F/B-EVAR have been well-characterized, studies on patient-reported quality of life (QOL) after F/B-EVAR have been limited in their use of non-specific instruments and measures. We report on disease-specific QOL in patients that underwent F/B-EVAR using a validated QOL survey for aortic aneurysms. MethodsProspectively maintained databases were used to contact living patients that underwent F/B-EVAR for pararenal or thoracoabdominal aortic aneurysms at two institutions. Eligible patients (n = 286) were asked to complete a disease-specific QOL survey previously validated in patients that underwent repair of an infrarenal abdominal aortic aneurysm. An emotional impact score (EIS) from 0-100 was derived from the survey with higher scores indicating more emotional impact and worse QOL. Respondent behavior change following F/B-EVAR was evaluated in four domains (strenuous activity, travel, heavy lifting, and sexual activity) previously identified by patients to be most impacted by an aortic aneurysm. ResultsIn total, 234 patients (82%) completed surveys. Mean post-operative interval to survey completion was 3.4 ± 2.8 years. Mean EIS was 16 (range 0-91) for all patients surveyed, with higher mean EIS among those within the first year after F/B-EVAR (20 vs 14). Most respondents demonstrated limited adverse emotional impact after F/B-EVAR. However, the 4th quartile of EIS was broad (22-91), indicating that a subset of respondents had significantly worse QOL after repair. While most patients reported no post-procedure change in each of the activity domains, over 40% of patients did report decrease in strenuous activity and heavy lifting after F/B-EVAR. Those with decreased activity after repair had corresponding deficiencies in disease-specific knowledge for the domains of heavy lifting (P <.001) and sexual activity (P = .17). ConclusionsThe majority of patients who underwent F/B-EVAR in this cohort had low emotional impact on their QOL after repair. One-quarter of patients did report significant post-procedure anxiety about their aneurysm, with improvement observed beyond one year after repair. Most patients reported unchanged or decreased activity levels following F/B-EVAR, and less aneurysm-specific patient knowledge was associated with decreased activity after repair. These findings are similar to those seen in prior work using this survey instrument in patients that underwent infrarenal aneurysm repair. This work confirms the feasibility of using this survey to evaluate QOL in patients with complex aortic disease. Longitudinal evaluation in these patients may identify those at high-risk for worse QOL after F/B-EVAR.

50182 Evaluating disease specific quality of life and chemoprevention utilization in patients with more than one lifetime skin cancer

50182 Evaluating disease specific quality of life and chemoprevention utilization in patients with more than one lifetime skin cancer

Long-term outcomes of mechanochemical ablation using the Clarivein device for the treatment of great saphenous vein incompetence

ObjectiveThe short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes. MethodsThis is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not. ResultsA total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly. ConclusionsIn over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.

Expanding revascularization trials to women and underserved minorities and shifting to patient-centered outcomes: RECHARGE trials program.

We review the limited available evidence informing coronary revascularization decisions in women and minorities, and introduce the RECHARGE trial program, which consists of two separate but integrated parallel multicenter, randomized trials comparing coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI), one exclusively enrolling women (RECHARGE:Women) and one exclusively enrolling Black or Hispanic patients (RECHARGE:Minorities). The extensive evidence base supporting coronary revascularization suffers from under-representation of women, minorities and minoritized populations, and the use of heterogeneous primary composite outcomes whose components have varying strengths of association with prognosis and quality-of-life (QOL). In RECHARGE, participants will be followed for up to 10 years, with QOL assessments at baseline, 30 days, 3 months, every 6 months for 3 years, and annually thereafter. The primary endpoint is the hierarchical composite of time to all-cause mortality, time-averaged change from baseline in the physical component of the SF-12v2 physical summary score, and time-averaged change from baseline in the mental component of the SF12v2 summary score, evaluated using a win ratio. Independently adjudicated major adverse cardiovascular and noncardiovascular events and disease-specific QoL will be secondary endpoints. The RECHARGE trials are the first revascularization trials to enroll exclusively women and minority patients and to use patient-centered outcomes as their primary outcome.

Association of Lifestyle Behaviors with Quality of Life in Patients with COPD: A Cross-Sectional Study in Primary Care.

Background/Objectives: The association between healthy lifestyle behaviors and their effect on quality of life among patients with COPD remains unclear. Therefore, the aim of this study was to explore the lifestyle behaviors and their association with the disease-specific quality of life among a primary care population with COPD in Greece. Methods: This cross-sectional study included 236 participants aged 40 years and older from the COCARE COPD study. The healthy lifestyle index (HLI) was created based on smoking, alcohol consumption, BMI, physical activity, and sleep duration, with each factor categorized as either healthy (1) or unhealthy (0). The HLI ranged from 0 (least healthy) to 5 (healthiest). COPD-specific quality of life was assessed using the COPD assessment test (CAT), where higher scores indicate poorer health status. Multiple logistic regression was used to analyze the association between HLI and CAT scores, adjusting for confounders. Results: Half of the participants were non-smokers or former smokers, while 92% reported consuming low levels of alcohol (less than 14 units per week). Additionally, 56% had a BMI below 30, indicating they were not obese. Surprisingly, only 32% engaged in regular exercise, with at least 150 min per week, and only 25% reported getting adequate sleep, ranging from 7 to 9 h per night. Importantly, poorer health status was inversely associated with non/former smoking (OR: 0.543, 95% CI: 0.282-1.049), physical activity (OR: 0.238, 95% CI: 0.122-0.463), and adequate sleep (OR: 0.337, 95% CI: 0.160-0.710). Patients with higher HLI scores were less likely to have poor health status. Conclusions: In conclusion, our findings indicate that a significant proportion of patients with COPD failed to adhere to a minimum of three out of five healthy behaviors. Additionally, a higher number of healthy lifestyle factors defined by a high HLI score were independently associated with a better disease-specific quality of life. This is particularly important for COPD where quality of life is in the epicenter of management. Therefore, healthcare providers could significantly improve the management of COPD and patient outcomes by targeting and improving these lifestyle behaviors with targeted and holistic intervention strategies.

An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study).

Aim: Real-world evidence on the management of hemorrhoidal disease (HD) is limited. This international study collected clinical practice data on the effectiveness of conservative treatments for acute HD on symptoms and quality of life (QoL), providing perspectives of treatment modalities from different continents. Patients & methods: The 4-week observational prospective CHORALIS study involved adult outpatients consulting for spontaneous complaints of hemorrhoids (graded using Goligher classification) and prescribed conservative treatments according to usual clinical practice. Assessments were: anal pain/discomfort (visual analog scale [VAS]), other signs/symptoms (patient questionnaire), Patient Global Impression of Change (PGI-C) questionnaire and disease-specific QoL (HEMO-FISS-QoL questionnaire). Results: Of 3592 participants, 3505 were analyzed (58.4% male; age 40.5±13.7years; history of HD in 48.4%; 72.1% Goligher grade I and II). Pain and discomfort were the most common symptoms. Most treatments were venoactive drugs (VADs; 90.9%), particularly micronized purified flavonoid fraction (MPFF; 73.7%) and diosmin (14.6%). All VAD-based therapies improved signs/symptoms (number/intensity/frequency of pain, discomfort, bleeding, swelling, itching and soiling) and QoL. MPFF was associated with a significantly greater proportion of patients with no symptoms (48.8 vs diosmin 34.4%, p<0.001), pain disappearance (69.7 vs diosmin 52.8%, p<0.001), treatment impact at 1week rated on PGI-C as 'very much better' (30.5 vs diosmin 17.9%, p<0.001) and shorter times to improvement (mean±SD 3.9±1.5days vs diosmin 4.2±1.7days). Conclusion: In this prospective real-world study of patients with acute HD, conservative therapies consisting mainly of VADs, including MPFF, improved the clinical signs and symptoms of disease, as well as QoL. This study evidence supports clinical advantages associated with VADs, mostly MPFF, for effectively managing acute HD.

Comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence: protocol for a multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial (REBORN trial)

IntroductionEndovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is...

Health-Related Quality of Life in Psoriasis: Literature Review.

The assessment of quality of life (QoL) in patients with psoriasis plays a crucial role in understanding the impact of the disease and evaluating treatment outcomes. We provide an overview of the key measures used to assess QoL in psoriasis patients, including both generic and psoriasis-specific instruments. The limitations and strengths of instruments such as the Dermatology Life Quality Index (DLQI), Skindex, and Psoriasis Disability Index (PDI) are discussed, highlighting their psychometric properties and areas for improvement. Furthermore, this review examines the potential of disease-specific QoL measures in providing greater sensitivity to disease-related burden and change compared to generic instruments. However, most of the available psoriasis-specific patient-reported outcome measures need further validation. We aim to provide valuable insights into the importance of using validated QoL measures in clinical practice and research, ultimately contributing to a more comprehensive assessment of the impact of psoriasis on patients' lives and enhancing the evaluation of treatment interventions.

Polish cross-cultural adaptation of a disease-specific quality-of-life instrument: The Penn Acoustic Neuroma Quality-of-Life Scale.

The medical community has shown a growing interest in developing methods for measuring and comparing objective patient outcomes coupled with subjective patient assessments. Questionnaires enable healthcare professionals to obtain the patient's perspective about their experienced vestibular schwannomas (VS) symptoms quickly. To date, in Poland, a cross-cultural adapted version of a disease-specific questionnaire for the measurement of quality of life (QoL) in patients with VS has not been produced. This study aimed to adapt the questionnaire evaluating disease-specific QoL in patients with VS (Penn Acoustic Neuroma Quality-of-Life Scale; PANQOL) to Polish and evaluate its psychometric properties. One-hundred twenty-four patients aged between 24 and 85 years (mean (M) = 60.17 ±standard deviation (SD) = 13.27) diagnosed with VS and treated with Gamma Knife were included in the study. We used a questionnaire translated from English into Polish by a bilingual professional, verified through a back-translation. The final version consisted of 26 items. The internal consistency of the Polish version of the PANQOL scale domains was measured using the Cronbach's alpha (α). To verify the validity of PANQOL subscales, a correlation analysis was conducted between the domains of PANQOL and other questionnaires, including the Assessment of Quality of Life (AQoL-8D), the Glasgow Benefit Inventory (GBI), the 5 Well-Being Index (WHO-5), the Skarzynski Tinnitus Scale (STS) for the presence of dizziness, and the Gardner-Robertson classes. The majority of PANQOL domains showed excellent or good internal consistency (for a PANQOL total of 0.934; for subscales in the range of 0.916-0.424). Our analysis showed strong correlations between the total PANQOL score and AQoL-8D utility score, as well as between the subscales. We observed weak to moderately significant relationships between GBI and PANQOL domains (r = 0.18-0.43), the WHO-5 (r = 0.18-0.56) and the STS scale (r = -0.40- -0.19). The results demonstrated that the POL-PANQOL is a reliable and valid questionnaire for measuring QoL.

Effectiveness of ClariFix (Cryoablation) of the Posterior Nasal Nerve on Nasal Symptoms in Patients With Chronic Rhinitis: A Systematic Review and Meta-Analysis

Background and Objectives: The present study evaluated the efficacy of cryoablation of the posterior nasal nerve in alleviating symptoms associated with chronic rhinitis.Methods: A systematic review of pertinent literature sourced from PubMed, Scopus, Embase, Web of Science, and Cochrane databases was conducted through May 2024. The analysis focused on studies that appraised changes in quality of life and rhinitis-associated symptomatology before and after cryoablation treatment.Results: A total of seven studies (495 patients) were included in the analysis. Significant improvements in rhinitis-related symptoms were observed in patients undergoing cryoablation, irrespective of etiology (allergic or nonallergic rhinitis). Furthermore, cryoablation yielded improvements in disease-specific quality of life, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire. Notably, a clinically significant reduction (≥30% decrease from baseline) in total nasal symptomatology was noted in 71% of cases following cryoablation. Regarding the incidence of adverse effects, nasal dryness, epistaxis, ocular symptoms, and palatal numbness occurred in &lt;5% of patients, while postoperative pain occurred in 10% and headache in 20% of patients who underwent treatment. In subtype analysis, the total nasal symptom score in nonallergic rhinitis showed a significantly increasing pattern over time (p=0.0017).Conclusion: Cryoablation of the posterior nasal nerve appears to yield a decrease in subjective nasal symptom scores and an improvement in disease-specific quality of life. Notably, these effects persisted for up to 12 months post-treatment, with marked improvements observed in both allergic and nonallergic rhinitis subtypes.